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This randomized, pilot study explores the activity of olanzapine with or without delayed dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic cancer receiving the combination of carboplatin and paclitaxel. Women treated with this regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in women receiving carboplatin and paclitaxel.
The purpose of this study is to assess if the use of olanzapine can improve control of delayed nausea and vomiting in women receiving the combination of carboplatin and paclitaxel for a gynaecologic cancer. Patients are randomized to one of three treatment arms. Please see the "Arms and Intervention" sections for more detailed information. The primary objective is to determine in each treatment group the proportion of patients achieving Complete Protection (CP; no vomiting, no rescue anti-emetics, and no more than mild nausea) during the delayed phase (days 2-5 post-chemotherapy) in the first chemotherapy cycle. The secondary objectives are:
Protocol treatment is to begin ≤14 days of registration. Patients will receive treatment on Days 1-3. Patients will be permitted to take rescue therapy of the treating investigator's choice based on the clinical circumstances. After completing treatment, patients will be monitored for side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine Days 1-3 | Experimental | Olanzapine + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as the following anti-nausea/vomiting drugs:
|
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| olanzapine+Dexamethasone d 1-3 | Experimental | Olanzapine + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as the following anti-nausea/vomiting drugs:
|
|
| dexamethasone days 1-3 | Active Comparator | Dexamethasone + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as usual anti-nausea/vomiting drugs:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Protection | Proportion of patients achieving delayed Complete Protection, defined as no vomiting, no rescue anti-emetics, and no more than mild nausea measured by the Nausea and Vomiting Daily Diary/Questionnaire. | days 2-5 post-chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea scores | • Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving Complete Response | • Proportion of patients achieving Complete Response, defined as no emetic episodes and no use of rescue anti-emetics measured by the Nausea and Vomiting Daily Diary/Questionnaire. | up to 5 days |
| Impact of nausea and vomiting on daily life activities |
Inclusion Criteria:
bone marrow: absolute neutrophil count >=1,500/L, platelets >=100,000/L liver: bilirubin 1.5 x upper limit of normal (ULN); transaminases <=2.5 x ULN kidney: creatinine <=1.5 x ULN
• Able to take oral medications
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Celio, MD | Contact | 0039 02 2390 | 2597 | luigi.celio@istitutotumori.mi.it |
| trialcenter trialcenter | Contact | 0039 02 2390 | 3824 | trialcenter@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Celio, MD | Istituto tumori | Study Chair |
| Domenica Lorusso, MD | Istituto tumori | Principal Investigator |
| Gabriella Saibene, PharmD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale dei Tumori | Recruiting | Milan | Milan | 20133 | Italy |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D000077924 | Palonosetron |
| D003907 | Dexamethasone |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
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| Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine | Drug | all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1 |
|
• Impact of nausea and vomiting on daily life activities as measured by the Functional Living Index-Emesis Questionnaire. |
| day 1 (pre-chemotherapy) and day 6 (post-chemotherapy) |
| Incidence of potential toxicities related to olanzapine | • Incidence of potential toxicities related to olanzapine as measured by the Nausea and Vomiting Daily Diary/Questionnaire. [Time frame: ] [Designated as safety issue: Yes] | up to 5 days |
| Frequency of rescue anti-emetics | • Frequency of rescue anti-emetics measured by the Nausea and Vomiting Daily Diary/Questionnaire. | up to 5 days |
| Istituto Tumori |
| Principal Investigator |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |